Chapter 4731-21 Drug Treatment of Intractable Pain

(A)
"Addiction" means a compulsive disorder
in which an individual becomes preoccupied with obtaining and using a
substance, despite adverse social, psychological and/or physical consequences,
the continued use of which results in a decreased quality of life. Physical
dependence alone is not evidence of addiction.

(B)
"Believes" or "has reason to believe"
does not require absolute certainty or complete unquestioning acceptance; but
only an opinion based on reasonable information that a patient is suffering
from addiction or drug abuse or engaging in diversion of drugs.

(D)
"Diversion" means the
conveyance of a prescription drug to a person other than the person for whom
the drug was prescribed or dispensed by a practitioner.

(E)
"Drug abuse" means a maladaptive or
inappropriate use or overuse of a medication.

(F)
"Emergency" means an unforeseen
combination of circumstances or the resulting state that calls for immediate
action.

(G)
"Intractable pain"
means a state of pain that is determined, after reasonable medical efforts have
been made to relieve the pain or cure its cause, to have a cause for which no
treatment or cure is possible or for which none has been found. "Intractable
pain" does not include pain experienced by a patient with a terminal condition.
"Intractable pain" does not include the treatment of pain associated with a
progressive disease that, in the normal course of progression, may reasonably
be expected to result in a terminal condition.

(H)
"Pain" means an unpleasant sensory and
emotional experience associated with actual or potential tissue damage, or
described in terms of such damage.

(I)
"Physical dependence" means a physiologic
state of adaptation to a specific drug or medication characterized by the
development of a withdrawal syndrome following abrupt cessation of a drug or on
administration of an antagonist.

(1)
An individual holding a
certificate to practice medicine and surgery or osteopathic medicine and
surgery under Chapter 4731. of the Revised Code;

(2)
An individual holding a certificate to
practice podiatric medicine and surgery under Chapter 4731. of the Revised Code
and practicing within his or her scope of practice as defined in section
4731.51 of the Revised Code; or

(a)
A certificate to practice
as a physician assistant under Chapter 4730. of the Revised Code and practicing
within his or her scope of practice in compliance with that chapter; and

(b)
A certificate to prescribe
under Chapter 4730. of the Revised Code and exercising physician delegated
prescriptive authority in compliance with that chapter.

(K)
"Prescription drug" means a
drug which under state or federal law may be administered or dispensed only by
or upon the order of a practitioner and includes the term "dangerous drug" as
defined by section 4729.02 of the Revised Code.

(L)
"Protracted basis" means for a
period in excess of twelve continuous weeks.

(M)
"Terminal condition" means an
irreversible, incurable, and untreatable condition caused by disease, illness,
or injury, which will likely result in death. A terminal condition is one in
which there can be no recovery, although there may be periods of remission.

A terminal condition shall be determined to a reasonable degree
of medical certainty in accordance with reasonable medical standards by a
patient's attending medical doctor or doctor of osteopathic medicine and one
other individual holding a certificate under Chapter 4731. of the Revised Code
to practice medicine and surgery or osteopathic medicine and surgery who has
examined the patient.

(N)
"Tolerance" means decreasing response to the same dosage of a prescription drug
over time as a result of physiologic adaptation to that drug.

(A)
When utilizing any prescription drug for
the treatment of intractable pain on a protracted basis or when managing
intractable pain with prescription drugs in amounts or combinations that may
not be appropriate when treating other medical conditions, a practitioner shall
comply with accepted and prevailing standards of care which shall include, but
not be limited to, the following:

(1)
An
initial evaluation of the patient shall be conducted and documented in the
patient's record that includes a relevant history, including complete medical,
pain, alcohol and substance abuse histories; an assessment of the impact of
pain on the patient's physical and psychological functions; a review of
previous diagnostic studies and previously utilized therapies; an assessment of
coexisting illnesses, diseases or conditions; and an appropriate physical
examination;

(2)
A medical
diagnosis shall be established and documented in the patient's medical record
that indicates not only the presence of intractable pain but also the signs,
symptoms, and causes and, if determinable, the nature of the underlying disease
and pain mechanism;

(3)
An
individualized treatment plan shall be formulated and documented in the
patient's medical record. The treatment plan shall specify the medical
justification of the treatment of intractable pain by utilizing prescription
drugs on a protracted basis or in amounts or combinations that may not be
appropriate when treating other medical conditions, the intended role of
prescription drug therapy within the overall plan, and, when applicable,
documentation that other medically reasonable treatments for relief of the
patient's intractable pain have been offered or attempted without adequate or
reasonable success. The prescription drug therapy shall be tailored to the
individual medical needs of each patient. The practitioner shall document the
patient's response to treatment and, as necessary, modify the treatment plan;

(a)
The practitioner's diagnosis of
intractable pain shall be made after having the patient evaluated by one or
more other practitioners who specialize in the treatment of the anatomic area,
system, or organ of the body perceived as the source of the pain. For purposes
of this rule, a practitioner "specializes" if the practitioner limits the whole
or part of his or her practice, and is qualified by advanced training or
experience to so limit his or her practice, to the particular anatomic area,
system, or organ of the body perceived as the source of the pain. The
evaluation shall include review of all available medical records of prior
treatment of the intractable pain or the condition underlying the intractable
pain; a thorough history and physical examination; and testing as required by
accepted and prevailing standards of care. The practitioner shall maintain a
copy of any report made by any practitioner to whom referral for evaluation was
made under this paragraph. A practitioner shall not provide an evaluation under
this paragraph if that practitioner would be prohibited by sections
4731.65 to
4731.69 of the Revised Code or
any other rule adopted by the board from providing a designated health service
upon referral by the treating practitioner; and

(b)
The practitioner shall not be required to
obtain such an evaluation, if the practitioner obtains a copy of medical
records or a detailed written summary thereof showing that the patient has been
evaluated and treated within a reasonable period of time by one or more other
practitioners who specialize in the treatment of the anatomic area, system, or
organ of the body perceived as the source of the pain and the treating
practitioner is satisfied that he or she can rely on that evaluation for
purposes of meeting the further requirements of this chapter of the
Administrative Code. The practitioner shall obtain and review all available
medical records or detailed written summaries thereof of prior treatment of the
intractable pain or the condition underlying the intractable pain. The
practitioner shall maintain a copy of any record or report of any practitioner
on which the practitioner relied for purposes of meeting the requirements under
this paragraph; and

(5)
The practitioner shall ensure and document in the patient's record that the
patient or other individual who has the authority to provide consent to
treatment on behalf of that patient gives consent to treatment after being
informed of the benefits and risks of receiving prescription drug therapy on a
protracted basis or in amounts or combinations that may not be appropriate when
treating other medical conditions, and after being informed of available
treatment alternatives.

(B)
Upon completion and satisfaction of the
conditions prescribed in paragraph (A) of this rule, and upon a practitioner's
judgment that the continued utilization of prescription drugs is medically
warranted for the treatment of intractable pain, a practitioner may utilize
prescription drugs on a protracted basis or in amounts or combinations that may
not be appropriate when treating other medical conditions, provided that the
practitioner continues to adhere to accepted and prevailing standards of care
which shall include, but not be limited to, the following:

(1)
Patients shall be seen by the
practitioner at appropriate periodic intervals to assess the efficacy of
treatment, assure that prescription drug therapy remains indicated, evaluate
the patient's progress toward treatment objectives and note any adverse drug
effects. During each visit, attention shall be given to changes in the
patient's ability to function or to the patient's quality of life as a result
of prescription drug usage, as well as indications of possible addiction, drug
abuse or diversion. Compliance with this paragraph of the rule shall be
documented in the patient's medical record;

(2)
Some patients with intractable pain may
be at risk of developing increasing prescription drug consumption without
improvement in functional status. Subjective reports by the patient should be
supported by objective data. Objective measures in the patient's condition are
determined by an ongoing assessment of the patient's functional status,
including the ability to engage in work or other gainful activities, the pain
intensity and its interference with activities of daily living, quality of
family life and social activities, and physical activity of the patient.
Compliance with this paragraph of the rule shall be documented in the patient's
medical record;

(3)
Based on
evidence or behavioral indications of addiction or drug abuse, the practitioner
may obtain a drug screen on the patient. It is within the practitioner's
discretion to decide the nature of the screen and which type of drug(s) to be
screened. If the practitioner obtains a drug screen for the reasons described
in this paragraph, the practitioner shall document the results of the drug
screen in the patient's medical record. If the patient refuses to consent to a
drug screen ordered by the practitioner, the practitioner shall make a referral
as provided in paragraph (C) of this rule;

(4)
The practitioner shall document in the
patient's medical record the medical necessity for utilizing more than one
controlled substance in the management of a patient's intractable pain; and

(5)
The practitioner shall
document in the patient's medical record the name and address of the patient to
or for whom the prescription drugs were prescribed, dispensed, or administered,
the dates on which prescription drugs were prescribed, dispensed, or
administered, and the amounts and dosage forms of the prescription drugs
prescribed, dispensed, or administered, including refills.

(C)
If the practitioner believes
or has reason to believe that the patient is suffering from addiction or drug
abuse, the practitioner shall immediately consult with an addiction medicine
specialist or other substance abuse professional to obtain formal assessment of
addiction or drug abuse.

(a)
Addiction medicine specialist
means a physician who is qualified by advanced formal training in addiction
medicine or other substance abuse specialty, and includes a medical doctor or
doctor of osteopathic medicine who is certified by a specialty examining board
to so limit the whole or part of his or her practice.

(b)
Substance abuse professional includes a
psychologist licensed pursuant to Chapter 4732. of the Revised Code and
certified as a clinical health psychologist, an independent chemical dependency
counselor, or a chemical dependency counselor III.

(a)
Document the recommendations
of the consultation in the patient's record;

(b)
Continue to actively monitor the patient
for signs and symptoms of addiction, drug abuse or diversion; and

(c)
Maintain a copy of any written report
made by the addiction medicine specialist or substance abuse professional to
whom referral for evaluation was made under this paragraph.

(3)
Prescription drug therapy may
be continued consistent with the recommendations of the consultation. If the
consulting addiction medicine specialist or other substance abuse professional
believes the patient to be suffering from addiction or drug abuse, prompt
referral shall be made to one of the following:

(a)
An addiction medicine specialist or
substance abuse professional; or

The board encourages those practitioners who encounter patients
with intractable pain in the usual course of their practices to complete
continuing medical education related to the treatment of intractable pain,
including coursework related to pharmacology, alternative methods of pain
management and treatment, and addiction medicine.

(A)
Physical dependence and tolerance by
themselves do not indicate addiction.

(B)
Physical dependence and tolerance are
normal physiological consequences of extended opioid therapy, and do not, in
the absence of other indicators of drug abuse or addiction, require reduction
or cessation of opioid therapy.

A violation of any provision of any rule in this chapter of the
Administrative Code, as determined by the board, shall constitute "failure to
use reasonable care discrimination in the administration of drugs," as that
clause is used in division (B)(2) of section
4731.22 of the Revised Code;
"selling, prescribing, giving away, or administering drugs for other than legal
and legitimate therapeutic purposes," as that clause is used in division (B)(3)
of section 4731.22 of the Revised Code, if
done knowingly or recklessly, as those words are defined in section
2901.22 of the Revised Code; and
"a departure from, or the failure to conform to, minimal standards of care of
similar practitioners under the same or similar circumstances, whether or not
actual injury to a patient is established," as that clause is used in division
(B)(6) of section 4731.22 of the Revised Code.

(2)
The
treatment of pain associated with a progressive disease that, in the normal
course of progression, may reasonably be expected to result in a terminal
condition;

(3)
Treatment utilizing
only drugs that do not exert their effects at the central nervous system level;
and

(4)
Treatment utilizing only
drugs that are not controlled substances and are classified as antidepressants.

(B)
A practitioner who
treats intractable pain by utilizing prescription drugs is not subject to
disciplinary action by the board under section
4731.22 of the Revised Code
solely because the practitioner treated the intractable pain with prescription
drugs. The practitioner is subject to disciplinary action only if the
prescription drugs are not utilized in accordance with section
4731.052 of the Revised Code and
the rules adopted under this chapter of the Administrative Code.

(C)
A Medical doctor or doctor of osteopathic
medicine who provides comfort care as described in division (E)(1) of section
2133.12 of the Revised Code to a
patient with a terminal condition is not subject to disciplinary action by the
board under section 4731.22 of the Revised Code if
the treatment of pain for a patient with a terminal condition is provided
pursuant to the requirements of section
2133.11 of the Revised Code.